Drug to Treat Severe Food Allergies Including Nuts Gets FDA Approval
Medicine
Published: Feb. 19, 2024, 4:19 p.m. ET
By Brooke Steinberg
The FDA greenlights a new drug to reduce severe food allergies
The Food and Drug Administration recently approved a new drug that has the potential to transform the lives of individuals with severe food allergies. Known as Xolair or omalizumab, the drug has been given the green light to help reduce severe allergic reactions to certain foods in adults and children above the age of 1, with the ultimate aim of reducing the risk of anaphylaxis resulting from accidental exposure.
Non-emergency use and the importance of continued food allergen avoidance
It is important to note that Xolair does not serve as a treatment during an allergic reaction. Instead, it is designed to be repeatedly administered every two to four weeks to gradually reduce the risk of future allergic reactions. Patients who are prescribed Xolair are also required to continue avoiding foods they are allergic to in order to maximize its effectiveness.
A new breakthrough in food allergy treatment
Kelly Stone, M.D., Ph.D., associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, acknowledged the significance of this approval: “This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies. While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”
Xolair’s previous use and trials
Xolair, developed by Genentech, had previously been approved for the treatment of moderate-to-severe persistent allergic asthma, chronic hives, and chronic inflammatory sinus disease with nasal polyps. A recent study sponsored by the National Institute of Allergy and Infectious Diseases demonstrated that Xolair also helped some patients tolerate small amounts of peanut, milk, egg, and cashew over time. Common side effects of Xolair include reactions at the injection site and fever.
Looking toward a better future for food allergy management
Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, emphasized the significance of Xolair’s approval: “Xolair offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens. Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”
